Ketamine for Pain in the Emergency Department



Status:Not yet recruiting
Conditions:Chronic Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:21 - Any
Updated:3/31/2019
Start Date:May 1, 2019
End Date:December 2020
Contact:Gabrielle Procopio, PharmD
Email:Gabrielle.Procopio@hackensackmeridian.org
Phone:5519964368

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Comparison of Ketamine 0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg Intravenous Doses for Acute Pain in the Emergency Department: A Prospective, Randomized, Double-blind, Active-controlled, Clinical Trial

This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score
reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2
mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also
examine the frequency of adverse events secondary to ketamine including fatigue, dizziness,
nausea, headache, feeling of unreality, changes in hearing or vision, mood changes,
generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory
analysis based on the need for rescue analgesia within two hours of ketamine administration,
adequate pain relief, previous opioid tolerance, and age (adults < 65 years old and > 65
years old).

A literature review was performed that searched for randomized clinical trials involving
ketamine IV boluses for acute pain in the Emergency Department. Studies involving continuous
infusions or intranasal routes of ketamine administration were not included. Thirteen
randomized clinical trials were identified meeting this criteria. None of these trials
directly compared ketamine doses within the 0.1-0.3 mg/kg range for pain score reduction and
adverse events. Many of these trials concluded with the recommendation that further studies
were needed to evaluate the optimal dosing of ketamine for acute pain and determine which
populations are most ideal for its use. This study will be the first to evaluate ketamine for
acute pain in the emergency department at standard of care doses (0.1 mg/kg, 0.2 mg/kg, and
0.3 mg/kg IV) to determine which dose correlates with the most efficacy and safety.

This study will include the following procedures:

- Patient consent, screening, and enrollment will be performed by the treating resident or
attending who will remain blinded

- Patient will be assigned a subject number

- Treating resident or attending will notify the ED pharmacist that a patient has been
enrolled in the trial

- ED pharmacist will notify the IV room and place the study drug order

- Either the ED pharmacist or a pharmacy supervisor will randomize the subject based on
the predetermined randomization list

- Study drug will be prepared as 0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg IV dose in a 100 mL
solution of dextrose 5% or sodium chloride 0.9%

- ED pharmacist will promptly deliver the study drug to the ED

- Baseline vital signs will be assessed prior to starting the study drug infusion

- Study drug will be administered via IV infusion over 20 minutes

- Treating resident or attending will reassess the patient at 15 minutes from the end of
infusion, at 30 minutes from the end of infusion, and then every 30 minutes for up to
120 minutes or until discharge, whichever is sooner

Inclusion Criteria:

- Acute pain (including acute on chronic pain)

- Pain score of moderate to severe (> 4/10) on the Numerical Rating Scale

- Provider determines the patient requires intravenous ketamine for analgesia

Exclusion Criteria:

- History of hypersensitivity to ketamine

- Altered mental status

- Psychiatric illness

- Known history of renal or hepatic insufficiency

- Acute head or eye injury

- Suspected intracranial hypertension or mass

- Headache as the chief complaint

- Alcohol or drug abuse

- Received an analgesic within the last four hours

- History of congestive heart failure

- History of aortic or brain aneurysm

- Active Chest Pain

- Porphyria

- Active methadone treatment

- Pregnant or breastfeeding

- Signs of respiratory, hemodynamic, or neurologic compromise

- Systolic blood pressure < 90 mmHg or > 180 mmHg

- Heart rate < 50 beats per minute or > 150 beats per minute

- Respiratory rate < 10 breaths per minute or > 30 breaths per minute

- Glasgow Coma Score < 15

- Previously received ketamine < 0.3 mg/kg IV for acute pain in the emergency department
We found this trial at
1
site
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Gabrielle Procopio, PharmD
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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mi
from
Hackensack, NJ
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